Seal anchor for use in surgical procedures

ABSTRACT

A surgical apparatus for positioning within a tissue tract accessing an underlying body cavity, includes a seal anchor member comprising a compressible material and being adapted to transition between a first expanded condition to facilitate securing of the seal anchor member within the tissue tract and in substantial sealed relation with tissue surfaces defining the tissue tract and a second compressed condition to facilitate at least partial insertion of the seal anchor member within the tissue tract. The seal anchor member defines a central longitudinal axis and has leading and trailing ends. At least one longitudinal object port extends between the leading and trailing ends and is adapted for reception of a surgical object whereby compressible material defining the at least one longitudinal object port is adapted to deform to establish a substantial sealed relation with the object. The seal anchor member includes at least two separable anchor segments dimensioned to be positioned in adjacent stacked relation to selectively alter the longitudinal length of the seal anchor member to accommodate tissue tracts of different lengths.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/223,336 filed Sep. 1, 2011, now U.S. Pat. No. 8,864,659, which claimsbenefit of U.S. Provisional Application No. 61/416,511 filed Nov. 23,2010, and the disclosures of each of the above-identified applicationsare hereby incorporated by reference in their entirety.

BACKGROUND

1. Technical Field

The present disclosure relates to a seal for use in a surgicalprocedure. More particularly, the present disclosure relates to a sealanchor apparatus adapted for insertion into an incision in tissue, and,for the sealed reception of one or more surgical objects such that asubstantially fluid-tight seal is formed with both the tissue and thesurgical object, or objects.

2. Background of the Related Art

Today, many surgical procedures are performed through small incisions inthe skin, as compared to the larger incisions typically required intraditional procedures, in an effort to reduce both trauma to thepatient and recovery time. Generally, such procedures are referred to as“endoscopic”, and when performed on the patient's abdomen, is referredto as “laparoscopic”. Throughout the present disclosure, the term“minimally invasive” should be understood to encompass both endoscopicand laparoscopic procedures.

During a typical minimally invasive procedure, surgical objects, such assurgical access devices, e.g., trocar and cannula assemblies, orendoscopes, are inserted into the patient's body through the incision intissue. In general, prior to the introduction of the surgical objectinto the patient's body, insufflation gasses are used to enlarge thearea surrounding the target surgical site to create a larger, moreaccessible work area. Accordingly, the maintenance of a substantiallyfluid-tight seal is desirable so as to prevent the escape of theinsufflation gases and the deflation or collapse of the enlargedsurgical site.

To this end, various valves and seals are used during the course ofminimally invasive procedures and are widely known in the art. However,a continuing need exists for an apparatus that can be inserted directlyinto the incision in tissue and that can accommodate tissue tracts ofvarying lengths and a variety of surgical objects while maintaining theintegrity of an insufflated workspace.

SUMMARY

A surgical apparatus for positioning within a tissue tract accessing anunderlying body cavity, includes a seal anchor member comprising acompressible material and being adapted to transition between a firstexpanded condition to facilitate securing of the seal anchor memberwithin the tissue tract and in substantial sealed relation with tissuesurfaces defining the tissue tract and a second compressed condition tofacilitate at least partial insertion of the seal anchor member withinthe tissue tract. The seal anchor member defines a central longitudinalaxis and has leading and trailing ends. At least one longitudinal objectport extends between the leading and trailing ends and is adapted forreception of a surgical object whereby compressible material definingthe at least one longitudinal object port is adapted to deform toestablish a substantial sealed relation with the object. The seal anchormember includes at least two separable anchor segments dimensioned to bepositioned in adjacent stacked relation to selectively alter thelongitudinal length of the seal anchor member to accommodate tissuetracts of different lengths. Each anchor segment defines longitudinalobject port segments adapted to be aligned when in the adjacent stackedrelation to define the at least one longitudinal object port of the sealanchor member. The seal anchor member may include at least three anchorsegments with each of the anchor segments defining the longitudinalobject port segments. Means for securing the anchor segments injuxtaposed stacked relation may be provided.

The seal anchor member may include a supplemental longitudinal opening.An elongate securing member may be positionable within the secondarylongitudinal opening of the seal anchor member. The securing member isdimensioned and adapted to retain the at least three anchor segments inthe adjacent stacked relation. The at least three anchor segments mayinclude supplemental opening segments in communication with each otherwhen the at least three anchor segments are in the adjacent stackedrelation. The supplemental opening segments define the supplementallongitudinal opening of the seal anchor member to receive the securingmember. Each of the at least three anchor segments include first andsecond supplemental opening segments in communication with each otherwhen the at least three anchor segments are in the adjacent stackedrelation. The first and second supplemental opening segments definefirst and second longitudinal openings of the seal anchor member toreceive the securing member.

First and second securing members may be positionable within the firstand second supplemental longitudinal openings respectively to retain theat least three anchor segments in the adjacent stacked relation. Thesecuring member may include a flexible filament, or, in the alternative,may be a substantially rigid element.

The at least three anchor segments may include a leading anchor segment,a trailing anchor segment and an intermediate anchor segment. At leastone of the leading and the trailing anchor segments having a flangeportion to facilitate retention of the seal anchor member relative tothe tissue tract. Each of the leading and the trailing anchor segmentsmay include a flange portion to facilitate retention of the seal anchorrelative to the tissue tract.

The at least one longitudinal object port may be in general longitudinalalignment with the central longitudinal axis of the seal anchor member.A plurality of longitudinal object ports may be provided.

The seal anchor member may comprise one of a foam material or a gelmaterial.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described hereinbelowwith references to the drawings, wherein:

FIG. 1 is a front perspective view of the seal anchor apparatus;

FIG. 2 is a top view of the seal anchor apparatus of FIG. 1;

FIG. 3 is a longitudinal cross-sectional view of the seal anchorapparatus of FIG. 1;

FIG. 4 is a plan view with parts separated of a seal anchor apparatusillustrating a plurality of anchor segments and a pair of securingelements for securing the anchor segments in adjacent stacked relation;

FIG. 5 is a longitudinal sectional view illustrating the anchor segmentsin the adjacent stacked relation with the securing elements andpositioned within a tissue tract, and further illustrating a surgicalobject positioned within one of the object seal ports;

FIG. 6 is a sectional view similar to the view of FIG. 5 illustrating analternate securing element for securing the anchor segments; and

FIG. 7 is a longitudinal sectional view similar to the view of FIG. 6illustrating an alternate embodiment of the seal anchor apparatus with asurgical trocar positioned within the apparatus.

DETAILED DESCRIPTION OF THE EMBODIMENTS

In the drawings and in the description which follows, in which likereferences numerals identify similar or identical elements, the term“proximal” or “trailing” will refer to the end of the apparatus which isclosest to the clinician during use, while the term “distal” or“leading” will refer to the end which is furthest from the clinician, asis traditional and known in the art.

Referring to FIGS. 1-3, there is disclosed a surgical seal anchorapparatus for use in single incision surgery. Surgical apparatus 10 isdisclosed in commonly assigned U.S. patent application Ser. No.12/578,832, filed Oct. 14, 2009 the entire contents of which disclosureare incorporated by reference herein. Surgical apparatus 10 is flexibleor compressible to allow it to be inserted through a single incision inthe body of a patient such that after insertion it will expand and sealwithin the incision. Additionally, the flexible nature of accessassembly 10 allows a surgical instrument or object inserted therethroughto be manipulated about its axis and thus allow a higher degree ofmovement of the surgical instrument to orient it relative to the tissuebeing operated upon. Examples of surgical instruments or objects usablewith surgical apparatus 10 include clip appliers, graspers, dissectors,retractors, staplers, laser probes, photographic devices, endoscopes andlaparoscopes, tubes, and the like. Such instruments or objects will becollectively referred to herein as “objects”.

Surgical apparatus 10 includes a flexible body or port 12 defining asingle lumen 16. Proximal or trailing and distal or leading ends 16 a,16 b, respectively, of lumen 16 may be tapered, as shown, to facilitateinsertion of a surgical object therethrough. Port 12 may be formed ofvarious materials such as, for example, silicone, thermoplasticelastomers (TPE), rubber, foam, gel, etc. In this manner, port 12 ofaccess assembly 10 may be compressed or squeezed and inserted through anincision in the body of a patient. In one embodiment, port 12 includesTPE material that is infused with an inert gas, e.g. CO₂ or Nitrogen, toform a foam structure. Port 12 may be coated with a lubricant, e.g.Parylene N or C, in order to create a lubricious surface finish on allexternal surface. Various other coatings, e.g., hydrophilic,hydrophobic, bio-agents, anti-infection, analgesic, may also be employedto modify the properties of access assembly 10. In this manner, thecoating facilitates insertion of port 12 into an incision and insertionof instruments therethrough.

Port 12 defines a substantially hourglass shape when viewed from theside, includes a central portion 22 having an upper rim or flange 24located at a proximal end 26 of central portion 22 and a lower rim orflange 28 located at a distal end 30 of central portion 22. Upper rim 24and lower rim 28 aid in minimizing movement of access assembly 10longitudinally through an incision or tissue tract formed in a patient.Central portion 22 is of a length sufficient that upper rim 24 ismaintained external the body while lower rim 28 is received within theabdominal cavity. As shown, upper and lower rims 24, 28, respectively,are substantially identical in size and shape. It is envisioned,however, that upper and lower rims 24, 28 may be of a different size andor shape.

Lumen 16 extends through port 12 and defines longitudinal axisconfigured to receive surgical instrument in a sealing manner. Lumen 16may include a protective coating or sleeve (not shown), extending thelength of port 12 to prevent tearing of access assembly 10 duringinsertion and removal of surgical instruments. The sleeve or coating mayalso facilitate insertion and removal of surgical instruments 50. Thesleeves may be integrally formed with port 12, or instead may besecurely affixed to port 12 using adhesive, ultrasonic welding or othersuitable means.

Referring now to FIG. 4, one embodiment of the seal anchor apparatus 100of the present disclosure is illustrated. Seal anchor apparatus 100includes seal anchor 102 having a plurality of anchor segments 104 a-104e. Anchor segments 104 a-104 e are separable and are arranged to bepositioned in adjacent stacked relation. The number of anchor segments104 a-104 e utilized in a given procedure will be conditional upon thelength of the tissue tract through which seal anchor 102 will bepositioned. Moreover, the quantity of anchor segments 104 a-104 eutilized is selected in accordance with the length of the tissue tract.One or more anchor segments 104 a-104 e may be selected and utilized toperform the surgical procedure. Each anchor segment 104 a-104 e may befabricated from any of the aforedescribed materials and be adapted totransition between compressed and expanded conditions for deploymentwithin the tissue tract.

Anchor segments 104 a, 104 e are the trailing (or proximal) and leading(or distal) anchor segments, respectively. Each of anchor segments 104a, 104 e may have an annular, peripheral or circumferential flange 106at its respective trailing or leading ends and an anchor base 108.Flanges 106 define an enlarged cross-sectional dimension relative toanchor base 108 of anchor segments 104 a, 104 e. Flanges 106 assist inmaintaining the seal anchor 102 within the tissue tract by engaging theexternal and internal surfaces of the tissue tract. Anchor bases 108 maybe cylindrical in shape although other configurations are envisioned aswell. Anchor bases 108 generally reside within the tissue tract when theseal anchor apparatus 100 is appropriated positioned within the tract.

Anchor segments 104 b, 104 e, 104 d are the intermediate anchor segmentsand may define a cross-section substantially similar to the crosssection of anchor base 108 of trailing and leading anchor segments 104a, 104 e; however, it is possible that the cross-sections of anchorsegments 104 b, 104 c, 104 d may vary to correspond to the dimensioningof the tissue tract.

Seal anchor apparatus 100 also includes one or more elongated securingelements 110 which assist in maintaining anchor segments 104 a-104 e inadjacent stacked relation as will be discussed.

Referring now to the cross-sectional view of FIG. 5, in conjunction withFIG. 4, when assembled in adjacent stacked relation, anchor segments 104a-104 e define at least one longitudinal object port 112 extendingthrough seal anchor 102 and relative to the longitudinal axis “k” of theseal anchor 102. Object port 112 is adapted to receive a surgical objectin substantial sealed relation therewith, i.e., the internal surfacesdefining the object port 112 engage the object and establish asubstantial seal about the outer surfaces of the object. In particular,each anchor segment 104 a-104 e defines a respective object port segment112 a-112 e extending through the anchor segment 104 a-104 e. Whenanchor segments 104 a-104 e are appropriately arranged in the adjacentstacked relation, port segments 112 a-112 e may be aligned to define onecontinuous object port extending through seal anchor 102. In FIG. 5, twoobject ports 112 are shown having respective port segments 112 a-112 ein longitudinal alignment.

Seal anchor 102 further defines one or two supplemental longitudinalopenings 114 extending the longitudinal length of the seal anchor 102.For example, each anchor segment 104 a-104 e may include supplementalopening segments 114 a-114 e extending through the respective anchorsegments 104 a-104 e, which, when the anchor segments 104 a-104 e areappropriately assembled, the supplemental opening segments 114 a-114 eare aligned to define the continuous supplemental longitudinal openings114. Two supplemental longitudinal openings 114 are depicted in FIG. 5.

Supplemental longitudinal openings 114 are dimensioned to receive one ormore elongated securing elements 110 which function in securing orretaining the anchor segments 104 a-104 e in the adjacent stackedrelation. Securing elements 110 extend through supplemental openingsegments 114 a-114 e of each anchor segment 104 a-104 e. In oneembodiment depicted in FIG. 5, securing elements 110 may be relativelyrigid and have lips 116 adjacent its leading end with a cross-sectiongreater than the cross-section of a supplemental longitudinal opening114 to engage the leading anchor segment 114 e. In another embodimentdepicted in FIG. 6, the securing element is a single flexible filamentwhich is passed though longitudinal supplemental openings 114 wherebythe free ends of the filament extend in a proximal or trailing directionfrom trailing anchor segment 104 a. The free ends 110 a may be tied(shown in phantom) to secure the anchor segments 104 a-104 e to eachother.

Referring again to FIG. 5, seal anchor member 102 is shown positionedwithin a tissue tract “t”. Flanges 106 and trailing and leading anchorsegments 106 a, 106 b are shown engaging the external and internalsurfaces adjacent the tissue tract “t”. An object “o” is positionedwithin one longitudinal object port 112.

The use of access assembly 10 in a single incision surgical procedurewill now be described. A tissue tract “t” is established through bodytissue to access an underlying tissue site. The tissue tract “t” may beperformed with a trocar, scalpel or the like, or may be a natural bodyorifice or channel. The length of the tissue tract is approximated bythe clinician. Thereafter, anchor segments 104 a-104 e are assembledwith one or more of the leading and trailing anchor segments 104 a, 104e and one or more of the intermediate anchor segments 104 b-104 darranged in adjacent stacked relation. The number of anchor segments 104a-104 e utilized generally will correspond to the length of the tissuetract, and this will be decided by the clinician. The longitudinalobject port segments 112 a-112 e and supplemental opening segments 114a-114 e of the anchor segments 102 a-102 e are longitudinally aligned.One or more securing members 110 are positioned within the supplementallongitudinal openings 114 to secure the anchor segments 104 a-104 e toeach other.

The seal anchor 102 is advanced within the tissue tract “t”. Duringinsertion, the individual anchor segments 104 a-104 e may be compressedto permit advancement through the tissue tract. Once appropriatelypositioned within the tissue tract, the anchor segments 104 a-104 e willattempt to return to their inherent expanded condition which, therebyeffects a seal of the outer surfaces of the anchor segments 104 a-104 erelative to the tissue tract “t”. One or more surgical instruments orobjects “o” are introduced through object ports 112 of the seal anchor102 to perform one or more surgical tasks. Object ports 112 establish asubstantial sealed relation with the surgical objects as discussed.

FIG. 7 illustrates an alternate embodiment where seal anchor member 200includes a centrally positioned object port 202 in general alignmentwith the central longitudinal axis “k” of seal anchor member 200. Sealanchor member 200 includes a plurality of anchor segments 200 a-200 ehaving object port segments 202 a-202 e and supplemental openingsegments 204 a-204 e. Object port segments 202 a-202 e and supplementalopening segments 204 a-204 e are aligned when the anchor segments 202a-202 e are in stacked relation to define one or more longitudinalobject ports 202 for passage of a surgical object and one or moresupplemental opening 204 for reception of a securing member as discussedin connection with the earlier embodiments.

A cannula 300 may be introduced within object port 202. One suitablecannula 300 is disclosed in commonly assigned U.S. Patent Publication No20060224120 to Smith et al., the entire contents of which disclosure arehereby incorporated by reference herein. Cannula 300 includes cannulahousing 302 and cannula sleeve 304 extending from the cannula housing302. An instrument seal may be disposed within the cannula housing 302to establish a substantial sealed relation about an instrument insertedtherethrough. One suitable instrument seal is disclosed in commonlyassigned U.S. Pat. No. 7,244,244 to Racenet, the entire contents ofwhich disclosure are hereby incorporated by reference herein. The sealmember disclosed in the Racent '244 patent may comprise a resilientcenter material (e.g., polyisoprene or natural rubber) with first andsecond layers of fabric at the respective proximal and distal surfacesof the resilient material and impregnated with the resilient material.The fabric may be of any suitable fabric for example, a SPANDEX materialcontaining about 20% LYCRA and about 80% NYLON available from Milliken,In FIG. 7, a surgical instrument or object “o” is shown introducedwithin cannula 300 and has an end effector “e” for performing a surgicaltask.

Although the illustrative embodiments of the present disclosure havebeen described herein with reference to the accompanying drawings, theabove description, disclosure, and figures should not be construed aslimiting, but merely as exemplifications of particular embodiments. Itis to be understood, therefore, that the disclosure is not limited tothose precise embodiments, and that various other changes andmodifications may be effected therein by one skilled in the art withoutdeparting from the scope or spirit of the disclosure.

What is claimed is:
 1. A surgical apparatus for positioning within atissue tract accessing an underlying body cavity, comprising: a sealanchor member transitionable between an expanded condition and acompressed condition, the seal anchor member including a distal end, aproximal end, a longitudinal length defined between the proximal anddistal ends, and a plurality of anchor segments selectively arranged insuperposed relation along a longitudinal axis defined by the seal anchormember, each anchor segment defining an object port segment and asupplemental port segment spaced apart from the object port segment, theobject port segments being aligned to define a longitudinal object portconfigured to receive a surgical object therethrough, the supplementalport segments being aligned to define a longitudinal supplemental portdimensioned to receive a securing member configured to retain theplurality of anchor segments in the superposed relation along thelongitudinal axis of the seal anchor member, wherein the object portsegment of a proximal-most anchor segment of the plurality of anchorsegments is obstructed from the supplemental port segment of theproximal-most anchor segment such that the longitudinal object port andthe longitudinal supplemental port are completely closed off from oneanother along the entire length of the seal anchor member.
 2. Thesurgical apparatus according to claim 1, wherein the longitudinal objectport is configured to receive the surgical object in a sealing relation.3. The surgical apparatus according to claim 1, wherein the seal anchormember comprises one of a foam material or a gel material.
 4. Thesurgical apparatus according to claim 1, wherein the securing member iscoupled to the distal end of the seal anchor member.
 5. The surgicalapparatus according to claim 4, wherein the securing member includes aflexible filament.
 6. The surgical apparatus according to claim 4,wherein the securing member includes a rigid element.
 7. The surgicalapparatus according to claim 1, wherein the seal anchor member includesat least three anchor segments.
 8. The surgical apparatus according toclaim 1, wherein the plurality of anchor segments include a leadinganchor segment, a trailing anchor segment, and an intermediate anchorsegment, at least one of the leading or the trailing anchor segmentshaving a flange portion.
 9. The surgical apparatus according to claim 8,wherein the leading and the trailing anchor segments each include aflange portion.
 10. The surgical apparatus according to claim 1, whereinthe seal anchor member further defines a plurality of longitudinalobject ports.
 11. A surgical apparatus for positioning within a tissuetract accessing an underlying body cavity, comprising: a seal anchormember transitionable between an expanded condition and a compressedcondition, the seal anchor member including a distal end, a proximalend, a longitudinal length defined between the proximal and distal ends,a plurality of anchor segments arranged in superposed relation along alongitudinal axis defined by the seal anchor member, each anchor segmentselectively removable, the seal anchor member defining a longitudinalobject port configured to receive a surgical object therethrough, and alongitudinal channel dimensioned to receive a securing member configuredto retain the plurality of anchor segments in the superposed relationalong the longitudinal axis of the seal anchor member, wherein aproximal-most portion of the longitudinal channel is obstructed from aproximal-most portion of the longitudinal object port when the pluralityof anchor segments are arranged in the superposed relation along thelongitudinal axis of the seal anchor member such that the longitudinalobject port and the longitudinal channel are completely closed off fromone another along the entire length of the seal anchor member.
 12. Thesurgical apparatus according to claim 11, wherein each anchor segmentdefines a port segment, the port segments of the plurality of anchorsegments being aligned to define the longitudinal object port extendingbetween distal and proximal ends of the seal anchor member.
 13. Thesurgical apparatus according to claim 11, wherein the securing member iscoupled to a distal end of the seal anchor member.
 14. The surgicalapparatus according to claim 11, wherein the plurality of anchorsegments include a leading anchor segment, a trailing anchor segment,and an intermediate anchor segment, at least one of the leading or thetrailing anchor segments having a flange portion.
 15. The surgicalapparatus according to claim 14, wherein the leading and the trailinganchor segments each include a flange portion.
 16. The surgicalapparatus according to claim 11, wherein the longitudinal object portextends along the entire length of the seal anchor member.